Trac Services | A-Z Of Regulatory Services | Regulatory Services | TRAC Services
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A to Z of Services

The consultancy for global, pharmaceutical regulatory affairs

A

  • Abridged Applications

An application for a product license which contains an active pharmaceutical ingredient (API) which has been previously tested and approved in other forms or for other companies.  The European Directives (in particular Directive 2001/83EC) allows for what is known as ‘abridged’ applications so that companies do not have to unnecessarily repeat the tests and trials on animals and humans.

  • Advertising and Promotion Advice

Within a country, any promotional material including product claims must be in line with the marketing authorisation for that product which has been granted by the appropriate regulatory authority for that market.

  • Agency Meetings

For complex regulatory submissions a meeting with the relevant regulatory agency to discuss any issues is advisable. The meetings follow a set agenda and the agency officials will only advise on issues that have been clearly set out in prior written correspondence.

B

  • Biotechnology Advice, Applications

A biotechnology product is one manufactured by recombinant DNA technology, one where genetic manipulation of cells is required, or a monoclonal antibody. In Europe, applications for these products are required to be submitted through the European Centralised procedure.

  • Bridging Studies and Reports

All PILs for medicines must reflect the results of consultation with target patient groups (user testing) but not every leaflet needs be the subject of a separate test. PILs may be able to rely on testing applied to PILs for similar products if adequate rationale is provided in a Bridging Report.

C

  • Centralised Submissions

The Centralised Procedure is an application for a single marketing authorisation across all countries in the EU and European Economic Area.  It is compulsory to follow the centralised procedure for products that fall into the EMA list of specified therapeutic uses or under a category of special designation. The MA holder can choose to follow the procedure for medicines with significant therapeutic, technical, scientific or public health interest.  The EMA is responsible for all applications made via the centralised procedure.

  • Certificates of Suitability (CEP) 

Certificates granted by the European Directorate for the Quality of Medicines (EDQM) to certify that the quality of a material produced by a given manufacturer can be suitably controlled by the requirements laid down in the relevant European Pharmacopoeia monograph.

  • Change of Ownership Submissions

A Change of Ownership Submission is made when a company wishes to transfer a licence from one company to another that is one legal entity to another.

  • Clinical Overview

The Clinical Overview provides a succinct critical analysis, discussion and interpretation of the clinical data provided in module 5 of the Common Technical Document.  The Overview reports the conclusions and the implications of the data as opposed to presenting the data itself however data should be referenced where relevant to the discussion.

  • Clinical Summary

The Clinical Summary provides a detailed summary of the clinical data provided in module 5 of the Common Technical Document.  The Summary reports observations regarding the data from the Biopharmaceutic, Clinical Pharmacology, Clinical Efficacy and Clinical Safety studies as opposed to the interpretation of the data.

An application made to a competent authority to gain approval to conduct a clinical trial programme in order to assess the safety and efficacy of a medicinal product in humans.  This process includes provision of non-clinical safety data, information on how the medicinal product has been developed and how the study will be conducted.  Following a positive assessment of the application, along with a favourable opinion by an ethics committee, the study may be granted a Clinical Trial Authorisation (CTA).

Review of the CMC (Module 3) information to ensure it meets the current regulatory requirements.

  • Common Technical Document (CTD) Formatting and Converting

The product Quality, Safety and Efficacy information is presented in a common format (called CTD – Common Technical Document ).  The CTD is organised into five modules. Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions. In July 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to the FDA.

D

  • Decentralised (DCP) submissions

Used when the applicant does not have a Marketing Authorisation for an EU country and wants to simultaneously obtain a marketing authorisation in several member states.  This method allows marketing roll out in a number of member states at the same time, resulting in shorter timeframes and reducing administrative burdens. One market will act as the Reference Member State (RMS) with all other involved markets acting as Concerned Member States (CMS’s).

  • Dossier Preparation and Review

Compilation of the product information into the appropriate format for regulatory submission.  Depending on what stage the product is in it’s lifecycle this information will include information regarding quality, safety and efficacy of the medicinal product.

  • Drug Development Advice

This will help to proactively understand and plan to to fulfill the information needed for successful regulatory submissions throughout the drug development process.

  • Due Diligence

The review of the regulatory dossier against current regulatory legislation and guidance to identify whether the documentation is submission ready.

E

eCTD (electronic Common Technical Document) is the electronic version of the CTD. It is mandatory for the Centralised Procedure and the preferred method of submission for MRP/DCP and national submissions in the EU. The eCTD contains individual documents as PDF files arranged in a hierarchical folder structure reflecting that of the CTD. An ‘XML backbone’ provides descriptive information about the files within the submission and describes their relationship to previous submissions, facilitating lifecycle management of a product.

G

  • Gap Analysis

The review of currently registered information against current manufacturing site practice to determine any differences (Gaps).  Each Gap is then assessed to determine whether a variation application will be required to update the registered detail to reflect current site practice. Gap analysis is often carried out for multiple markets simultaneously.

  • Generics Application

An application made to a competent authority to gain approval to market a generic product which can be authorised without its own clinical and pre-clinical testing data. A generic product has to meet the requirements described in Directive (2001/83).

I

A set of five ISO standards on the use, consumption and packaging of drugs to standardise the way the pharmaceutical industry refers to medicinal products.  Due to be implemented in July 2016, IDMP will provide a universal identification for drugs. The International Organization for Standardization (ISO) is an independent, non-governmental membership organization. It is the world’s largest developer of voluntary international standards which, when used, ensures products and services are safe, reliable and of good quality.

  • Investigational Medicinal Product Dossier (IMPD)

Forms the basis of a clinical trial application and includes summaries of information related to the quality, manufacture and control of the Investigational Medicinal Product (IMP) and placebo as applicable. This information is refined and developed through the phases of a clinical trial and is eventually contained within the Module 3 of a marketing authorisation application dossier. The IMPD also includes data from the non-clinical studies, and from any clinical use, with a critical analysis of the potential risks and benefits of the proposed trial. In certain circumstances a simplified IMPD can be submitted, when appropriate information has already been assessed as part of a previous application.

L

  • Line extensions

A line extension is a marketing authorisation application based on a product for which the applicant already holds marketing authorisation. The extension can be for the replacement of an active substance by a similar entity or for a different pharmaceutical form, route of administration or strength to the licenses already held by the applicant. A separate marketing authorisation is granted at the end of the line extension procedure.

Licence maintenance is the responsibility of the Marketing Authisation (or Product Licence) Holder throughout the lifetime of the product.  This ensures that the approved product can continue to be distributed and sold on the market.

M

Throughout a product’s lifecycle the marketing authorisation holder will review the product supply chain to ensure continuity of supply and also to identify any cost savings that could be made by moving manufacture of all or part of the API or product to an alternative manufacturing facility.  Any supply chain changes will require appropriate post-marketing regulatory activity to maintain the registered information in line with product being supplied to the market.

All medicines must obtain a Marketing Authorisation (MA) before they can be placed on the market. Medicines which meet the standards of safety, quality and efficacy are granted a MA. A Marketing Authorisation Application (MAA) is a common document which is submitted to the appropriate authority’s to assess for MA approval. Different types of applications exist and the type of application submitted  is dependent on the the products’s active ingredients, intended market and the regulatory strategy.

  • Mutual Recognition (MRP) Submissions

The Mutual Recognition Procedure (MRP) is used when a product has already received a Marketing Authorisation (MA) in a single Member State (MS) of the EU. The Country issuing the original MA acts as the ‘Reference Member State’ (RMS,) while countries that the Company wishes to market their drug in become ‘Concerned Member States’ (CMS). An MRP submission results in a national MA in each of the CMSs.

N

  • National Submissions

A National Submission is a single application to a national regulatory authority of one of the Member States (MS) of the EU. This can serve as the initial stage of the Mutual Recognition Procedure (MRP) and results in a single Marketing Authorisation (MA) valid in only one MS.

  • NeeS Submissions

NeeS (non-electronic Common Technical Document) format follows the same principle as eCTD, but without the XML backbone and the advantages of lifecycle management of a product. Table of Content documents are included in place of the XML backbone which allows internal hyperlinking but not to previous submissions. NeeS is very much an interim solution until industry and agencies are able to work completely in eCTD format.

  • Non-Clinical Overview

The Nonclinical Overview is an integrated and critical assessment of the pharmaceutical. It consists of the following sections- Overview of the nonclinical testing strategy, Pharmacology, Pharmacokinetics, Toxicology, Integrated overview and conclusions and Literature references.  The Integrated Overview and Conclusions section should reach well supported and logical conclusions regarding the safety of the product for the intended clinical use as demonstrated by the nonclinical studies.

  • Non-Clinical Summary

The nonclinical summary presents the Pharmacology, Pharmacokinetics and Toxicology studies that have been carried out on the pharmaceutical product.  It consists of an introduction which introduces the pharmaceutical and its intended use and three written and tabulated summaries- one each for Pharmacology, Pharmacokinetics and Toxicology sections. .Altogether the length of the 3 written summaries should not exceed 150 pages.

O

  • On-site Placement & Interim Management

Whilst most of the work we do for our clients is carried out from our offices in Cornwall we are also able to provide experienced personnel to work on-site for a client.  In addition, we can provide regulatory professionals to cover maternity leave or resource gaps during recruit.

  • Orphan Drug Development

Orphan medicinal products are used to diagnose, treat and prevent rare diseases.  A rare disease is defined as occurring in less than 5 per 10,000 individuals in the European Union. In 2000 the European Union (EU) implemented Orphan Drug Regulation (EC) No 141/2000 to promote research and development of orphan medicines in the EU to reduce the disparity.

P

  • Periodic Benefit Risk Evaluation Report (PBRER)

Previously known as a Periodic Safety Update Report (PSUR), a PBRER must be submitted to the authorities at defined time points for all approved medicinal products, whether they are on the market or not, to present and evaluate the risk-benefit balance of the product. This critical analysis must take into account any new or emerging safety information that can come from a number of sources including adverse event reporting from patients and healthcare professionals.

PIL Testing, also known as User testing or Readability Testing, is a research process used to assess if potential users can locate, understand and appropriately act upon the information contained within a leaflet. This follows the requirements of Article 59(3) of Directive 2001/83/EC as amended by Directive 2004/27/EC.

To plan and undertake the appropriate regulatory activity to ensure that the registered information remains current throughout the product lifecycle.

Q

  • QA/QP Release

In Europe a Qualified Person (QP) certifies that a batch of medicine is fit for human use as per the requirements of European Directive 2001/83/EC, before it can be released for sale. A Marketing Authorisation Holder is required to permanently and continuously have at their disposal the services of at least one Qualified Person.

  • Quality Overall Summary (QOS)

The Quality Overall Summary (QOS) forms part of Module 2 in the Common Technical Document (CTD). The QOS is a summary that follows the scope and the outline of the Body of data in Module 3 . The QOS does not include information, data or justification that was not already included in Module 3 or in other parts of the CTD.

R

The process to change the classification of an already licensed medicine from a prescription only medicine (POM) to a medicine available over the counter in a pharmacy (P). This process is reliant on sufficient pharmacovigilance data to indicate the product is safe for use off prescription.

  • Regulatory Compliance

A Marketing Authorisation Holder should always follow the documentation as agreed in the Marketing Authorisation. Periodically it may be necessary to review the current manufacturing and marketing practice to make sure it is in compliance with the registered regulatory documentation and current legislation.

  • Regulatory Strategy

The development of the most efficient regulatory plan and timeline for new product registrations or post-marketing product maintenance.  This can be at the local, regional or global level.

When a marketing authorisation (MA) is nearing the end of the approved licensing period it may be renewed on the basis of a re-evaluation of the risk-benefits.  The marketing authorisation holder (MAH) must supply a product overview, evidence to confirm quality compliance, changes to the original MA (variations) and reports of post-marketing experience (PSURs).

  • Response to Agency Questions

Following review of an application, the Regulatory Authority may respond to the applicant with questions. These must be responded to fully within the Authority’s stated deadline.  Any potential impact of the questions or responses on other applications should be assessed and any necessary action implemented.

S

  • Standard Operating Procedures (SOPs)

SOPs are detailed written instructions whose application is used to ensure consistency in specified activities. They are a quality control tool that can be used in many areas including standard business practices, Pharmacovigilance, Manufacturing and Clinical studies.

  • Substantial Amendments to Clinical Trial Applications

After the start of a clinical trial, the sponsor may make changes to the protocol. If those changes are likely to have a significant impact on the safety or physical or mental integrity of the clinical trial participants, and/or the scientific value of the trial, the sponsor must notify the competent authorities and/or ethics committee, which is known as a substantial amendment. The submission of a substantial amendment leads to a temporary halt of a trial until the changes are approved.

  • Summary of Product Characteristics (SmPC) Composition

The Summary of Product Characteristics (SmPC) contains information on how to use or prescribe a medicine and is used by healthcare professionals to ensure that medicines are used correctly.  SmPCs are written in a standard format and are required as part of a marketing authorisation (MA) for medicinal products.

V

A variation is required when details in the Marketing Authorisation have been changed. These changes can be purely administrative (such as a change in manufacturers address or company name), they can be revenue generating (registering a new Brand, indication or patient group), or they can be required for safety and quality reasons.